Tools / Drug approvals and letters / Drugs Ketorolac Tromethamine Relieves ocular itching due to seasonal allergic conjunctivitis. Sold as Toradol, Acular, Acular Preservative Free, Acular Ls, Sprix and 1 more. Every FDA application for this active ingredient: 7 branded and 57 generic.
As of Nov 15, 2026, FDA lists 64 applications for Ketorolac Tromethamine (sold as Toradol, Acular, Acular Preservative Free and others), first approved Nov 30, 1989, with 5 new uses approved and 0 published complete response letters.
First approved : Nov 30, 1989 Applications : 64 New uses approved : 5 Complete response letters : 0 Medicare spending, 2025 : $37.5M Shortage : Current
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Ketorolac Tromethamine Part D $32.1M -9% 1,073,203 Ketorolac Tromethamine Part B $3.4M +261% 1,436,175 Sprix Part D $2.0M +1% 169 Acular Part D $41K -8% 80 Acular Ls Part D $13K -39% 37
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change ACULAR LS 0.4% OPHTH SOL: $54.46 per ML Brand · 0% in a year
Shortages FDA's drug shortage list, as of Nov 13, 2026 Clinical Trials 31 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release Ventral Hernia, Ventral Hernia Repair · Northwestern University Phase 4 Recruiting Sep 24, 2026 Pain Control With Ketorolac and Nerve Block After Wrist and Hand Surgery Surgery, Upper Extremity · University of Chicago Phase 4 Recruiting Aug 19, 2026 Comparison of Ketorolac Tromethamine 0.5%-Soaked Bandage Contact Lenses Versus Non-Medicated Bandage Contact Lenses on Postoperative Pain Control After Photorefractive Keratectomy Refraction Error, Photorefractive Keratectomy · Madina Teaching Hospital Faisalabad Not applicable Not yet recruiting Jul 15, 2026 Midazolam Alone Versus Midazolam With Ketorolac for Sedation During Flexible Bronchoscopy. Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy · SYED HAIDER ALI Not applicable Not yet recruiting Jan 20, 2026 Comparison of Intranasal Ketorolac and Intranasal Ketamine in Digital Nerve Block Pain Pain, Digital Block · Tehran University of Medical Sciences Phase 3 Not yet recruiting Dec 26, 2025 Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy Postoperative Pain · University of South Alabama Phase 4 Not yet recruiting Dec 11, 2025 Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin Pain, Postoperative, Osteoarthritis, Knee · Assiut University Phase 2 / Phase 3 Not yet recruiting Jul 2, 2025 Non-Narcotic Pain Control After ACL Reconstruction ACL - Anterior Cruciate Ligament Rupture, ACL Injuries · The Cleveland Clinic Phase 2 Active, not recruiting May 15, 2025
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Nov 30, 1989 Toradol NDA 19698 · New molecular entity 12 Discontinued Dec 20, 1991 Toradol NDA 19645 · New dosage form 12 Discontinued Nov 9, 1992 Acular NDA 19700 · New dosage form 23 Marketed May 16, 1997 Ketorolac Tromethamine ANDA 74754 13 Marketed May 16, 1997 Ketorolac Tromethamine ANDA 74761 7 Marketed Jun 5, 1997 Ketorolac Tromethamine ANDA 74801 4 Discontinued Jun 5, 1997 Ketorolac Tromethamine ANDA 74802 27 Marketed Jun 26, 1997 Ketorolac Tromethamine ANDA 74790 0 Discontinued Sep 19, 1997 Ketorolac Tromethamine ANDA 74955 3 Discontinued Nov 3, 1997 Acular Preservative Free NDA 20811 · New dosage form 2 Discontinued Jan 27, 1999 Ketorolac Tromethamine ANDA 74993 12 Discontinued Apr 26, 1999 Ketorolac Tromethamine ANDA 75222 11 Discontinued Apr 26, 1999 Ketorolac Tromethamine ANDA 75228 9 Discontinued Jun 23, 1999 Ketorolac Tromethamine ANDA 75284 4 Discontinued Oct 25, 1999 Ketorolac Tromethamine ANDA 75230 0 Discontinued Nov 3, 1999 Ketorolac Tromethamine ANDA 75299 7 Discontinued Nov 29, 2000 Ketorolac Tromethamine ANDA 75348 0 Discontinued Jun 29, 2001 Ketorolac Tromethamine ANDA 75631 8 Discontinued Jul 24, 2001 Ketorolac Tromethamine ANDA 75626 7 Discontinued Jan 11, 2002 Ketorolac Tromethamine ANDA 75784 7 Marketed May 30, 2003 Acular Ls NDA 21528 · New dosage form 3 Marketed Jul 21, 2004 Ketorolac Tromethamine ANDA 75772 6 Marketed Jul 21, 2004 Ketorolac Tromethamine ANDA 76209 6 Marketed Jul 27, 2004 Ketorolac Tromethamine ANDA 76722 1 Marketed Oct 6, 2004 Ketorolac Tromethamine ANDA 76271 7 Marketed Oct 14, 2005 Ketorolac Tromethamine ANDA 77201 5 Discontinued Mar 27, 2007 Ketorolac Tromethamine ANDA 77943 5 Discontinued Mar 27, 2007 Ketorolac Tromethamine ANDA 77942 5 Marketed Jul 16, 2007 Ketorolac Tromethamine ANDA 78299 6 Discontinued Jan 14, 2008 Ketorolac Tromethamine ANDA 78145 4 Discontinued Oct 6, 2008 Ketorolac Tromethamine ANDA 78737 6 Discontinued Jul 22, 2009 Acuvail NDA 22427 · New formulation or manufacturer 5 Marketed Nov 5, 2009 Ketorolac Tromethamine ANDA 76109 4 Marketed Nov 5, 2009 Ketorolac Tromethamine ANDA 76583 1 Marketed Nov 5, 2009 Ketorolac Tromethamine ANDA 77308 3 Discontinued Nov 5, 2009 Ketorolac Tromethamine ANDA 78399 2 Discontinued Nov 5, 2009 Ketorolac Tromethamine ANDA 78434 1 Discontinued Nov 5, 2009 Ketorolac Tromethamine ANDA 78721 2 Discontinued Nov 5, 2009 Ketorolac Tromethamine ANDA 90017 1 Discontinued May 14, 2010 Sprix NDA 22382 · New dosage form 10 Marketed Nov 27, 2013 Ketorolac Tromethamine ANDA 91065 4 Marketed Feb 10, 2014 Ketorolac Tromethamine ANDA 203376 1 Discontinued Aug 4, 2014 Ketorolac Tromethamine ANDA 201155 5 Discontinued Oct 7, 2015 Ketorolac Tromethamine ANDA 203242 5 Marketed Nov 1, 2016 Ketorolac Tromethamine ANDA 204216 4 Marketed Sep 15, 2017 Ketorolac Tromethamine ANDA 209900 4 Marketed Aug 16, 2018 Ketorolac Tromethamine ANDA 210616 2 Marketed Nov 15, 2018 Ketorolac Tromethamine ANDA 205191 1 Discontinued Apr 5, 2019 Ketorolac Tromethamine ANDA 203410 0 Marketed Aug 20, 2020 Ketorolac Tromethamine ANDA 211445 3 Marketed Oct 20, 2020 Ketorolac Tromethamine ANDA 212939 3 Discontinued Dec 3, 2020 Ketorolac Tromethamine ANDA 205190 0 Discontinued Mar 23, 2022 Ketorolac Tromethamine ANDA 215788 1 Marketed Aug 25, 2022 Ketorolac Tromethamine ANDA 216651 1 Marketed Oct 21, 2022 Ketorolac Tromethamine ANDA 216407 1 Discontinued Oct 21, 2022 Ketorolac Tromethamine ANDA 217038 1 Marketed Nov 2, 2022 Ketorolac Tromethamine ANDA 214456 3 Marketed Feb 23, 2023 Ketorolac Tromethamine ANDA 215745 1 Marketed Feb 23, 2023 Ketorolac Tromethamine ANDA 216759 1 Marketed May 10, 2023 Ketorolac Tromethamine ANDA 217789 1 Marketed Jun 20, 2023 Ketorolac Tromethamine ANDA 217166 1 Marketed Mar 26, 2024 Ketorolac Tromethamine ANDA 218204 0 Marketed Sep 23, 2026 Ketorolac Tromethamine ANDA 218355 0 Marketed Sep 25, 2026 Ketorolac Tromethamine ANDA 221041 0 Marketed
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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